QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) announced results of operations for the second quarter and first half of 2012, delivering a solid performance and making significant progress on strategic initiatives to drive innovation and growth. QIAGEN also raised the outlook for full-year net sales and adjusted EPS targets and announced a program to repurchase up to $100 million of its shares.

In the second quarter of 2012, net sales grew 9% (+14% at constant exchange rates, or CER) to $307.2 million from the same period in 2011, as all customer classes, particularly Molecular Diagnostics and Applied Testing, and all regions recorded growth. Adjusted operating income rose 10% to $86.4 million, as the adjusted operating income margin was steady at 28% of net sales. Adjusted diluted earnings per share (EPS) grew to $0.25 from $0.23 in the 2011 quarter.

"As we execute on our strategic initiatives, QIAGEN is delivering a solid performance despite a challenging business environment. We are pleased with our results in the second quarter of 2012 and have raised our full-year outlook to reflect the success of actions we are taking. For the first time in our history, QIAGEN will launch a share repurchase program. This is a sign of our conviction about our future prospects, especially at a time when we believe our shares are undervalued," said Peer M. Schatz, Chief Executive Officer of QIAGEN N.V. "Our team is focused on growth drivers such as expanding placements of our QIAsymphony platform and adding valuable content across our customer classes and regions. In addition to accelerating organic growth, innovative products we gained in the acquisitions of Cellestis, Ipsogen and AmniSure have opened up new markets, and U.S. approval of our KRAS companion diagnostic will propel further growth in Personalized Healthcare. Our initiative to grow more efficiently and effectively is creating change for the better in all areas of the organization and we are reallocating resources to maximize value. QIAGEN is well positioned to achieve its goal to accelerate growth in 2012."

Growth in all geographic regions and customer classes drove the strong performance (+14% CER) in the second quarter of 2012. Sales of consumables and related revenues (+12% CER) and instruments (+28% CER) both advanced at double-digit rates. Contributions from recent acquisitions - Cellestis (as of August 29, 2011), Ipsogen (as of July 12, 2011) and AmniSure (as of May 3, 2012) - provided nine percentage points to growth, while the rest of the QIAGEN portfolio added five percentage points. Currency movements had a negative impact of five percentage points on reported sales growth.

Operating income declined 2% to $45.4 million in the second quarter of 2012 from $46.5 million in the 2011 quarter. Adjusted operating income, which excludes items such as restructuring and acquisition-related costs, equity-based compensation and amortization of intangible assets, rose 10% to $86.4 million from $78.7 million in the second quarter of 2011, with the adjusted operating income margin steady at 28% of net sales. The adjusted gross margin was 71% of net sales in the second quarter of 2012 compared to 73% in the same period of 2011.

Net income attributable to owners of QIAGEN N.V. was steady at $33.3 million compared to the second quarter of 2011. Diluted EPS in the second quarter of 2012 was unchanged at $0.14 (based on 240.2 million diluted shares) compared to the year-earlier period (based on 241.0 million diluted shares). Adjusted net income attributable to owners of QIAGEN N.V. rose 11% to $60.8 million from $55.0 million in the 2011 quarter, as adjusted diluted EPS rose to $0.25 in the second quarter of 2012 from $0.23 in the same period of 2011.

Reconciliations of reported results in accordance with U.S. generally accepted accounting principles (GAAP) to adjusted results are included in the tables accompanying this release.

"The strong increase in sales across QIAGEN's product portfolio, our global operations and focus on cost management drove double-digit growth in adjusted net income for the second quarter and first half of 2012," said Roland Sackers, Chief Financial Officer of QIAGEN N.V. "To grow more efficiently and effectively, QIAGEN is reallocating resources freed up by cost cutting to support our strategic initiatives. Thanks to the sustained growth of QIAGEN, we are able to invest in our businesses and also use a portion of our financial capacity to repurchase shares."

Net sales advanced at a double-digit pace in the first half of 2012, rising 10% (+14% CER) as the acquisitions of Cellestis, Ipsogen and AmniSure contributed eight percentage points to growth and the rest of the QIAGEN portfolio added six percentage points. Sales of consumables and related revenues (+13% CER) as well as instruments (+17% CER) benefited from the broad business improvement across all geographic regions and customer classes, particularly Molecular Diagnostics and Applied Testing. Currency movements had a negative impact of four percentage points on reported growth.

Operating income for the first half of 2012 declined 4% to $81.9 million from $84.9 million in the same period of 2011. Adjusted operating income, which excludes items such as restructuring and acquisition-related costs, equity-based compensation and amortization of intangible assets, rose 12% to $166.7 million from $149.2 million in the first half of 2011. The adjusted operating income margin improved to 28% of net sales in the first half of 2012 from 27% a year earlier. The adjusted gross margin was 71% of net sales in the 2012 period compared to 73% a year ago.

Net income attributable to owners of QIAGEN N.V. rose 1% to $61.9 million in the first half of 2012 from $61.3 million in the same period of 2011, while diluted EPS was $0.26 (based on 239.6 million diluted shares) compared to $0.25 (240.7 million diluted shares) in the year-ago period. Adjusted net income attributable to owners of QIAGEN N.V. grew 11% to $115.6 million in the first half of 2012, from $104.5 million in the 2011 period, as adjusted diluted EPS rose to $0.48 from $0.43.

Cash and cash equivalents at June 30, 2012, amounted to $214.0 million compared to $221.1 million at December 31, 2011. Net cash provided by operating activities decreased to $100.0 million in the first half of 2012 from $106.1 million in the same period of 2011, in part due to cash payments of $35.9 million for restructuring activities in the 2012 period. Net cash used in investing activities was $185.0 million (including cash payments of $131.8 million for acquisitions), up from $129.8 million in the 2011 period. Net cash provided by financing activities amounted to $78.0 million compared to $7.2 million in the first half of 2011, which was mainly due to a $68.9 million increase in debt.

Reconciliations of reported results in accordance with U.S. generally accepted accounting principles (GAAP) to adjusted results are included in the tables accompanying this release.

Business review

Geographic regions

In the second quarter of 2012, the Asia-Pacific / Japan region (18% of net sales, +20% CER) led the performance among geographic regions on contributions from Japan and China, particularly in Molecular Diagnostics. The Europe / Middle East / Africa region (35% of net sales, +18% CER) grew on expansion in Pharma and Molecular Diagnostics, driven by the QIAsymphony automation system as well as rapid growth in Personalized Healthcare. In the Americas (46% of net sales, +7% CER), Applied Testing gains and demand for the QuantiFERON latent TB test more than offset the expected decline in U.S. HPV (human papillomavirus) assay sales.

Product categories

Consumables and related revenues (86% of net sales, +12% CER) in the second quarter of 2012 benefited from contributions in all customer classes, led by double-digit growth in Molecular Diagnostics. For the first half of 2012, consumables and related revenues represented 87% of net sales and grew 13% CER compared to the same period in 2011.

Instrument sales (14% of net sales, +28% CER) in the second quarter of 2012 grew at a faster pace than consumables, driven by initiatives to secure new product placements such as the QIAsymphony automation portfolio and its Rotor-Gene Q real-time PCR platform. Applied Testing and Molecular Diagnostics delivered dynamic double-digit growth in instrument sales compared to the second quarter of 2011, a period with relatively soft demand. For the first half of 2012, instrument sales rose 17% CER compared to the same period in 2011 and represented 13% of net sales.

QIAGEN's sales growth is energized by a group of Molecular Diagnostics products that accounted for approximately 31% of net sales in the second quarter of 2012 and grew 54% CER compared to the same period in 2011. These growth drivers include the QIAsymphony automation platform, the QuantiFERON latent TB test acquired with Cellestis, the expanding portfolio of companion diagnostics in Personalized Healthcare (including blood cancer tests acquired with Ipsogen) and the AmniSure[] test for rupture of fetal membranes (ROM) in pregnant women, a widespread cause of premature delivery and neonatal complications.

Customer classes

An overview of performance in QIAGEN's four customer classes (based on total sales results that include organic growth and acquisitions at CER):

Molecular Diagnostics (Q2 2012: 48% of net sales, +22% CER) achieved solid gains in sales of both consumables and instruments, as the broad portfolio more than offset the expected decline in HPV sales. In Prevention, the QuantiFERON latent TB test delivered significant sales contributions, benefiting from the integration with QIAGEN and sales and marketing investments made after the acquisition of Cellestis in August 2011. Global HPV test sales (17% of total QIAGEN sales) declined approximately 6% CER for the first half of 2012 and by 12% in the second quarter. In the U.S. (13% of total QIAGEN sales), market conversion initiatives and the positive response by physicians to cervical cancer screening guideline updates in early 2012 were more than offset by the pricing effects of multiyear agreements implemented with many customers since early 2011. In particular in the U.S., QIAGEN is very successfully managing its leadership and market share in the more diversified competitive landscape following the entrance of competing products over the last few years, and continues to expect increasing volumes and a single-digit decline in HPV assay sales on a global basis for the full-year 2012. Personalized Healthcare grew at a strong double-digit pace on demand for companion diagnostic kits in Europe and Japan, with the Ipsogen blood cancer testing portfolio providing growth since the acquisition in July 2011. Milestone payments for co-development projects with pharmaceutical companies were also higher than in the year-ago period. In Profiling, sales rose in key markets for products used in disease analysis. In Point of Need, the second-quarter acquisition of the AmniSure assay further contributed to growth. In the first half of 2012, Molecular Diagnostics grew 21% CER and represented 47% of net sales.

Applied Testing (Q2 2012: 8% of net sales, +28% CER) delivered accelerated growth in the second quarter of 2012, as instrument sales doubled compared to the year-ago period. Consumables sales grew at a high single-digit pace. All regions showed double-digit growth, driven by human identification and forensic products. In the first half of 2012, Applied Testing advanced 26% CER and grew to 8% of net sales.

Pharma (Q2 2012: 20% of net sales, +8% CER) maintained a solid pace on higher sales of instruments and consumables, especially QIAGEN products used for molecular pathway analysis and biomarker development. Asia-Pacific / Japan led the performance, benefiting from the expansion of R&D activities, while the U.S. and Europe also provided contributions. In the first half of 2012, Pharma grew 9% CER and represented 20% of net sales.

Academia (Q2 2012: 24% of net sales, +1% CER) generated single-digit growth in consumables, while instrument sales declined slightly, in the second quarter of 2012. All regions provided contributions, with modest growth achieved in the U.S. and Europe despite the ongoing impact of budget uncertainty and austerity measures, which are expected to extend into the second half of the year. In the first half of 2012, Academia grew 2% CER and represented 25% of net sales.

Delivering growth at a faster pace in 2012

QIAGEN is delivering growth at a faster pace in 2012, reaping the benefits of the progress being made on strategic initiatives to drive growth and innovation. These initiatives focus on leveraging QIAGEN's leadership in Sample & Assay Technologies to (1) drive platform success, especially with the modular QIAsymphony automation platform; (2) add test content for use in all customer classes; (3) broaden geographic presence, especially in emerging markets; and (4) grow efficiently and effectively.

Drive platform success

A key element of QIAGEN's growth strategy is securing placements around the world of the QIAsymphony automation platform, the industry's first modular system that can process commercial assays as well as a broad range of laboratory-developed tests from sample to clinical result. Customer interest for this system continues to grow, particularly in Asia-Pacific and emerging markets, due to its unique profile and capabilities for use by a broad range of applications.

QIAGEN is well on track to achieve its year-end 2012 target for cumulative placements of more than 750 QIAsymphony automation platforms, adding more than 200 new systems during the year and building on the installed base of over 550 systems worldwide at the end of 2011. The Rotor-Gene Q MDx real-time PCR cycler, which is one of the modules in the QIAsymphony family, has received U.S. regulatory approval for use in healthcare laboratories with two QIAGEN diagnostic tests so far in 2012.

In June 2012, QIAGEN unveiled an advanced initiative to enter select segments of the field of next-generation sequencing (NGS) by adding a specialized automation platform paired with novel content. The initiative aims to offer complete workflows that will expand the use of NGS technologies, which currently focus on life science research, into new areas such as clinical research and molecular diagnostics. Overcoming the current challenges to clinical use of NGS technologies could lead to their adoption in areas such as exploratory diagnostics, the diagnosis of complex diseases and treatment of cancer patients. NGS technologies are also expected to complement established routine molecular technologies such as real-time PCR.

The first products from QIAGEN's NGS initiative are expected to launch in 2013, with a priority focus on clinical research in Academia and Pharma as well as select areas of Molecular Diagnostics such as Personalized Healthcare. The sample-to-result workflows will combine a broad range of QIAGEN products with a benchtop sequencer module now in late-stage development with Intelligent Bio-Systems, Inc., a U.S. company that QIAGEN acquired in 2012. These workflows will incorporate the QIAcube and QIAsymphony automation platforms to create sample-to-result solutions. They will maximize the value of QIAGEN's leadership in sample preparation solutions as well as the GeneGlobe (http://www.geneglobe.com) portfolio offering access to more than 60,000 well-defined and characterized molecular assays. New bioinformatics, including NGS solutions from a new collaboration with SAP AG, will handle the processing of large amounts of data produced in next-generation sequencing.

Add content

Building on the success of the modular QIAsymphony platform, QIAGEN is adding novel content for use on the broad range of instruments in its portfolio, particularly Rotor-Gene Q MDx.

A landmark addition of test content was achieved in July 2012 when QIAGEN received U.S. regulatory approval for its therascreen KRAS RGQ PCR Kit, which provides guidance on the use of Erbitux® (cetuximab) as a treatment in patients with metastatic colorectal cancer. This marked a milestone in QIAGEN's global expansion of its Personalized Healthcare franchise. Entry into the U.S. market with our first FDA-approved companion diagnostic builds on success in Europe and Japan, where QIAGEN already offers a range of Personalized Healthcare tests based on real-time PCR or Pyrosequencing.

QIAGEN is actively expanding its pipeline in companion diagnostics and plans to submit several other tests for U.S. regulatory approval in the coming years. The next U.S. submission is expected in 2012 involving a therascreen EGFR assay as a companion diagnostic for use with Boehringer Ingelheim's investigational medicine afatinib in patients with non-small cell lung cancer (NSCLC). Other submissions are expected to emerge from more than 15 projects QIAGEN has under way to co-develop and market companion diagnostics with leading pharmaceutical and biotech companies. In addition, QIAGEN is active in numerous partnerships and initiatives to further broaden its overall assay portfolio in Molecular Diagnostics as well as in other customer classes.

In line with its strategy to add novel content through targeted acquisitions, in May 2012 QIAGEN acquired AmniSure International LLC, a privately owned U.S. company, that has created the AmniSure assay, which detects a proprietary analyte that is highly sensitive and specific to rupture of fetal membranes, a condition in which fluid leaks from the amniotic sac prematurely. Growth of this product, which is approved in the U.S. and many markets worldwide, is expected to be catalytic to QIAGEN's Point of Need portfolio. AmniSure is expected to contribute approximately $12 million of sales to QIAGEN in 2012, but to be neutral to adjusted EPS as expansion investments are made.

Broaden geographic presence

QIAGEN continues to expand its geographic presence in attractive markets around the world, particularly the top seven emerging markets of Brazil, Russia, India, China, South Korea, Mexico and Turkey. These seven countries represented 12% of net sales in the second quarter of 2012 and generated 28% CER growth over the year-ago period. In the first half of 2012, these markets provided 11% of net sales and 27% CER growth.

Grow efficiently and effectively

Several actions are under way to help QIAGEN grow more efficiently and effectively. In the second quarter, organizational and leadership changes were announced to improve capabilities to address customer needs. The far-reaching changes, which took effect on July 1, included a redefinition of roles and accountabilities as well as organizational realignments.

A company-wide project launched in November 2011 to enhance productivity and free up resources for reallocation to strategic initiatives is producing changes throughout QIAGEN. Operational improvements are being made to focus R&D activities on high-growth areas in all customer classes, optimize capacity utilization at selected sites and capture savings from shared service functions and outsourcing. QIAGEN has set a goal of generating approximately $50 million of pre-tax savings in 2012, with the majority to be reinvested. Further restructuring charges may be taken during the course of 2012.

QIAGEN has passed a resolution to exercise the authorization granted by the General Meeting of Shareholders on June 27, 2012, and to purchase shares up to a total of $100 million (excluding transaction costs). Based on the closing price on July 23, this represents approximately six million shares. Details of the repurchase program will be announced before its actual commencement in line with Article 4, Section (2) of EC regulation 2273/2003 (so called Safe Harbour). Repurchased shares will be held in treasury in order to satisfy various obligations, which include exchangeable debt instruments and employee share-based remuneration plans.

QIAGEN is also reviewing its current debt structure and may take advantage of the currently low mid-to-long-term interest rates.

2012 outlook

Based on the strong performance in the first half of 2012, as well as taking into account the acquisition of AmniSure and the initiative to enter next-generation sequencing, QIAGEN has raised its outlook for net sales and adjusted earnings growth in 2012. For the full year, total net sales are now expected to rise approximately 8-9% CER (previously 6-8% CER) on a mix of contributions from the acquisitions of Cellestis and Ipsogen in 2011 and AmniSure in May 2012, as well as the rest of the business. Full-year reported sales are expected to be adversely affected by currency movements against the U.S. dollar, QIAGEN's reporting currency. Adjusted diluted earnings per share (EPS) are now expected to rise to approximately $1.04-1.06 for full-year 2012 (previously $1.03-1.05). This takes into account approximately $0.01 per share of dilution for investments in the next-generation sequencing initiative, which included the acquisition of Intelligent Bio-Systems. For the third quarter of 2012, net sales growth of approximately 9-10% CER is expected, and adjusted diluted EPS is expected to be approximately $0.25. These expectations do not take into account any further acquisitions that could be completed in 2012, the potential impact of share repurchases or the completion of any debt market transactions during the year.

Conference Call and Webcast Details

Information on QIAGEN's performance will be presented during a conference call on Wednesday, July 25, 2012, at 9:30 ET / 14:30 GMT / 15:30 CET. The corresponding presentation slides will be available for download shortly before the event at http://www.qiagen.com/goto/ConferenceCall, and a webcast will be available at this website. A replay will also be made available on this website.

Use of Adjusted Results

QIAGEN has regularly reported adjusted results, as well as results considered on a constant exchange rate basis, to give additional insight into its financial performance. These adjusted results include adjusted gross profit, adjusted operating income, adjusted net income attributable to owners of QIAGEN N.V. and adjusted diluted EPS. In addition, QIAGEN provides information on free cash flow, which it defines as net cash provided by operating activities minus purchases of property and equipment. Adjusted results are non-GAAP financial measures that QIAGEN believes should be considered in addition to the reported results prepared in accordance with generally accepted accounting principles, but should not be considered as a substitute. QIAGEN believes certain items should be excluded from adjusted results when they are outside of its ongoing core operations, vary significantly from period to period, or affect the comparability of results with its competitors and its own prior periods. Reconciliations of reported results to adjusted results are included in the tables accompanying this release.

QIAGEN N.V., a Netherlands holding company, is the leading global provider of Sample & Assay Technologies that are used to transform biological materials into valuable molecular information. Sample technologies are used to isolate and process DNA, RNA and proteins from biological samples such as blood or tissue. Assay technologies are then used to make these isolated biomolecules visible and ready for interpretation. QIAGEN markets more than 500 products around the world, selling both consumable kits and automation systems to customers through four customer classes: Molecular Diagnostics (human healthcare), Applied Testing (forensics, veterinary testing and food safety), Pharma (pharmaceutical and biotechnology companies) and Academia (life sciences research). As of June 30, 2012, QIAGEN employed approximately 4,000 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com/.

Certain of the statements contained in this news release may be considered forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. To the extent that any of the statements contained herein relating to QIAGEN's products, markets, strategy or operating results, including without limitation its expected operating results, new product developments, new product launches, regulatory submissions, and financing plans are forward-looking, such statements are based on current expectations and assumptions that involve a number of uncertainties and risks. Such uncertainties and risks include, but are not limited to, risks associated with management of growth and international operations (including the effects of currency fluctuations, regulatory processes and dependence on logistics), variability of operating results and allocations between customer classes, the commercial development of markets for our products in applied testing, personalized healthcare, clinical research, proteomics, women's health/HPV testing and nucleic acid-based molecular diagnostics; changing relationships with customers, suppliers and strategic partners; competition; rapid or unexpected changes in technologies; fluctuations in demand for QIAGEN's products (including fluctuations due to general economic conditions, the level and timing of customers' funding, budgets and other factors); our ability to obtain regulatory approval of our products; difficulties in successfully adapting QIAGEN's products to integrated solutions and producing such products; the ability of QIAGEN to identify and develop new products and to differentiate and protect our products from competitors' products; market acceptance of QIAGEN's new products, the consummation of acquisitions, and the integration of acquired technologies and businesses. For further information, please refer to the discussions in reports that QIAGEN has filed with, or furnished to, the U.S. Securities and Exchange Commission (SEC).